Europeiska unionen - kroatiska - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - Триоксид arsen - leukemija, promyelocytic, akutna - antineoplastična sredstva - arsenic trioxide medac is indicated for induction of remission, and consolidation in adult patients with:newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (apl) (white blood cell count, ≤ 10 x 10³/μl) in combination with all-trans-retinoic acid (atra)relapsed/refractory apl (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the pro-myelocytic leukaemia/retinoic-acid-receptor-alpha (pml/rarα) gene. brzina reakcije druge akutne mijeloične podtipovi leukemije do триоксида arsen ne smatra.

Europeiska unionen - kroatiska - EMA (European Medicines Agency)

centus biotherapeutics europe limited - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell - antineoplastična sredstva - bevacizumab u kombinaciji s kemoterapijom na bazi fluoropirimidina je indiciran za liječenje odraslih bolesnika s metastatskim karcinomom debelog crijeva ili rektuma. Бевацизумаб u kombinaciji s паклитакселом dizajniran za prvu liniju tretmana odraslih pacijenata s metastaze raka dojke . za daljnje informacije o stanju čovjeka epidermalnog faktora rasta receptora 2 (her2), molimo pogledajte odjeljak 5. Бевацизумаб u kombinaciji s капецитабином dizajniran za prvu liniju terapije bolesnika s metastaze raka dojke kod kojih je liječenje s drugim opcijama kemoterapije, uključujući таксаны ili антрациклины, smatra se neprikladnim. patients who have received taxane and anthracycline- containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with equidacent in combination with capecitabine. dodatne informacije o statusu her2 potražite u odjeljku 5. bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Бевацизумаб u kombinaciji s эрлотинибом, prikazan je za prva linija terapije kod odraslih pacijenata s нерезектабельными-najčešće metastaze ili recidivom неороговевающий немелкоклеточного raka pluća s epidermalnog faktora rasta (egfr) aktiviraju mutacije. bevacizumab in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer. bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iiib, iiic and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. bevacizumab, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor-targeted agents. Бевацизумаб u kombinaciji s паклитакселом i цисплатином ili паклитакселом i топотеканом kod pacijenata koji ne mogu dobiti платиновую terapiju, indiciran za liječenje odraslih bolesnika s uporni, relaps ili метастатической карциномой grlića maternice.

Bosnien och Hercegovina - kroatiska - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

rhei life d.o.o. bijeljina - amfotericin b - prašak za rastvor za infuziju - 50 mg/1 bočica - 1 bočica sadrži: 50 mg lipozomalnog amfotericina b

Europeiska unionen - kroatiska - EMA (European Medicines Agency)

koanaa healthcare gmbh - иматиниба мезилат - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - antineoplastična sredstva - imatinib koanaa is indicated for the treatment ofadult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. adult patients with relapsed or refractory ph+ all as monotherapy. adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. pacijenti koji imaju niske ili vrlo nizak rizik od recidiva, ne bi trebali primati adjuvantne terapije. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. osim po prvi put prijavljene kronične fazi kml, nema kontroliranih istraživanja pokazuju klinički učinak ili povećava stopu preživljavanja kod te bolesti.

Europeiska unionen - kroatiska - EMA (European Medicines Agency)

janssen-cilag international n.v.    - amivantamab - karcinom, ne-malih stanica pluća - antineoplastična sredstva - rybrevant as monotherapy is indicated for treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating epidermal growth factor receptor (egfr) exon 20 insertion mutations, after failure of platinum-based chemotherapy.

Europeiska unionen - kroatiska - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastična sredstva - dasatinib accord is indicated for the treatment of adult patients with:• ph+ acute lymphoblastic leukaemia (all) with resistance or intolerance to prior therapy. dasatinib accord is indicated for the treatment of paediatric patients with:• newly diagnosed ph+ all in combination with chemotherapy.

Europeiska unionen - kroatiska - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastična sredstva - dasatinib accordpharma is indicated for the treatment of adult patients with: newly diagnosed philadelphia chromosome positive (ph+) chronic myelogenous leukaemia (cml) in the chronic phase.  chronic, accelerated or blast phase cml with resistance or intolerance to prior therapy including imatinib.  ph+ acute lymphoblastic leukaemia (all) and lymphoid blast cml with resistance or intolerance to prior therapy. dasatinib accordpharma is indicated for the treatment of paediatric patients with: newly diagnosed ph+ cml in chronic phase (ph+ cml-cp) or ph+ cml-cp resistant or intolerant to prior therapy including imatinib.  newly diagnosed ph+ all in combination with chemotherapy.

Europeiska unionen - kroatiska - EMA (European Medicines Agency)

astellas pharma europe b.v. - enfortumab vedotin - carcinoma, transitional cell; urologic neoplasms - antineoplastična sredstva - padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor 1 or programmed death ligand 1 inhibitor.

Europeiska unionen - kroatiska - EMA (European Medicines Agency)

merck europe b.v. - tepotinib hydrochloride monohydrate - karcinom, ne-malih stanica pluća - antineoplastična sredstva - tepmetko as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

Europeiska unionen - kroatiska - EMA (European Medicines Agency)

novartis europharm limited  - capmatinib dihydrochloride monohydrate - karcinom, ne-malih stanica pluća - antineoplastična sredstva - tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum based chemotherapy.